PMA P010015S585

Device: Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S585
Product code: LWP
Decision date: 2026-04-23
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: updates to the software programs on the Medium Rate battery line at supplier, Medtronic Energy and Component Center

Current openFDA PMA Record#

Device: Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S585
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-04-23
Decision code: OK30
Date received: 2026-03-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updates to the software programs on the Medium Rate battery line at supplier, Medtronic Energy and Component Center